Catalog Number

-

Brand Name

Burkhart Dental Supply

Version/Model Number

72721163

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EEF

Product Code Name

Clamp, Rubber Dam

Public Device Record Key

c119cd56-0c74-457f-a916-fb2cc3918be9

Public Version Date

May 13, 2021

Public Version Number

1

DI Record Publish Date

May 05, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-